The June 2026 510(k) signal in one table
| Metric | June 2026 snapshot |
|---|---|
| Companies reviewed in filter | 86 |
| Companies listed | 7 named of 10 total |
| Total 510(k) clearances across top 10 | 65 |
| Respiratory & Sleep companies in top 10 | 7 |
| Respiratory & Sleep primary-lens companies in top 10 | 3 |
| Respiratory & Sleep mixed-lens companies in top 10 | 4 |
| Rehab & Neurotech companies in top 10 | 3 |
| Home Diagnostics companies in top 10 | 3 |
| Wearable Biosensors companies in top 10 | 1 |
Source labels: FDA counts and company names are from the FDA CDRH public database snapshot. Category lenses are Agence Octo Periscope classification, not FDA designations, and lens totals can overlap because one company may map to more than one Agence Octo lens. The 86-company filter is an Agence Octo methodology screen applied to the 2026-06-04 snapshot: companies were limited to those with at least one visible Class 2 510(k) clearance in the in-scope consumer-health lens universe, then ranked by clearance count within that filtered set. Company grouping follows Agence Octo methodology and can include practitioner-reported entity matching, parent-subsidiary normalization, or naming consolidation applied to the public record for sourcing analysis. These grouping steps are analytical conventions, not FDA-issued corporate determinations. ([FDA CDRH public database] + [Agence Octo methodology])
For transparency, this article names 7 of the 10 companies in the filtered June top-10 snapshot: Fisher & Paykel Healthcare, Ltd. (9), Sleepnet Corporation (6), Cepheid (6), Roche Molecular Systems, Inc. (6), Breas Medical AB (5), Abbott Molecular, Inc. (5), and Medline Industries, LP (5). Agence Octo is not disclosing the remaining three top-10 company names in this article, but they are included in the reported 65-clearance total for the filtered set. The concentration signal discussed here is therefore based on the seven named companies that map to Respiratory & Sleep under Agence Octo methodology, while the full top-10 total includes three unnamed companies outside this disclosure. It should be read as a partial top-10 disclosure, not a full published leaderboard. ([FDA CDRH public database] + [Agence Octo methodology])
Which companies are driving the Respiratory & Sleep 510(k) concentration?
Three of the 10 companies in the filtered top-10 set sit directly in Respiratory & Sleep as their primary lens in this snapshot:
- Fisher & Paykel Healthcare, Ltd. — 9 clearances — New Zealand
- Sleepnet Corporation — 6 clearances — United States
- Breas Medical AB — 5 clearances — Sweden
Four more companies appear in mixed lenses that include Respiratory & Sleep:
- Cepheid — 6 clearances — Home Diagnostics, Respiratory & Sleep
- Roche Molecular Systems, Inc. — 6 clearances — Home Diagnostics, Respiratory & Sleep
- Abbott Molecular, Inc. — 5 clearances — Home Diagnostics, Respiratory & Sleep
- Medline Industries, LP — 5 clearances — Rehab & Neurotech, Respiratory & Sleep
That is how the June count reaches 7 of 10: 3 primary-lens Respiratory & Sleep companies plus 4 mixed-lens companies that also map into Respiratory & Sleep under Agence Octo methodology. The lens count is therefore a classification view, not a count of seven pure-play respiratory specialists. ([Agence Octo methodology])
That stack does not prove one thing. It does set the burden of proof.
A dense Respiratory & Sleep cluster can reflect repeat filing behavior, broad accessory ecosystems, line extensions, or active product activity visible in FDA records. It does not, on its own, prove OEM openness, factory availability, or white-label readiness. For related signal reads, see Agence Octo's Periscope coverage of FDA-cleared company patterns by category to separate repeat filers from one-off appearances and mixed-lens diagnostics players. ([FDA CDRH public database] + [Agence Octo methodology])
What buyers should notice
1) Why is Respiratory & Sleep crowded at the 510(k) clearance-holder level?
Seven out of 10 is not a minor skew inside this filtered snapshot. It suggests buyers entering sleep or respiratory-adjacent consumer health are looking at a category where multiple companies already have active FDA-cleared product footprints visible in public records. In practical terms, the 65-clearance total means this top-10 group is not showing up through one-off filings alone; there is enough repeat activity in the filtered set to justify a tighter shortlist screen before outreach. ([FDA CDRH public database] + [Agence Octo methodology])
For sourcing teams, crowded categories change the question. The first question is no longer, "Who has clearance?" The better question is, "Who has clearance in a product form and operating model that matches the deal I want?" ([Agence Octo methodology])
2) Why do repeat 510(k) filings matter more than one-off visibility?
A single cleared 510(k) can mean a company reached the US market once.
A stack of repeat clearances can suggest a company has stayed active across product iterations, accessories, variants, or adjacent SKUs. That is a stronger commercialization indicator than a one-device story, but it is still only one sourcing signal. ([Agence Octo methodology])
This is why Fisher & Paykel Healthcare, Sleepnet, Breas, Cepheid, Roche, Abbott, and Medline stand out in this month's concentration read. They are not just present. They are visible repeatedly in the public record. ([FDA CDRH public database])
3) Does company country tell you the operating model?
The digest shows 5 US companies, 2 China-based companies, 1 Singapore company, 1 New Zealand company, and 1 Sweden company in the top 10.
Country is a clue. It is not the conclusion.
A US clearance holder may still manufacture abroad. A China-based clearance holder may still be selective about partnership structure. A Singapore or New Zealand filer may control product strategy while using a distributed manufacturing base. Read the filing geography as a sourcing signal, not regulatory confirmation of factory structure. ([FDA CDRH public database] + [Agence Octo methodology])
The companies to watch in this cluster
If your scouting brief sits in respiratory support, sleep interfaces, home diagnostics tied to respiratory demand, or adjacent consumables, these names are the visible concentration points in June:
| Company | Country | Clearances | Why it stands out in this snapshot |
|---|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | NZ | 9 | Highest-volume Respiratory & Sleep specialist among the seven named companies in the filtered June snapshot |
| Sleepnet Corporation | US | 6 | Multiple mask-related clearances visible in the FDA record |
| Breas Medical AB | SE | 5 | Repeat filings in respiratory device lines |
| Cepheid | US | 6 | Respiratory-linked diagnostics presence |
| Roche Molecular Systems, Inc. | US | 6 | Repeat respiratory diagnostics visibility |
| Abbott Molecular, Inc. | US | 5 | Diagnostic menu depth tied to respiratory demand |
| Medline Industries, LP | US | 5 | Cross-lens presence including respiratory products |
This is not a recommended-vendor list. It is a shortlist of where June's public clearance density is visible within Agence Octo's filtered consumer-health lens universe based on the seven named companies disclosed here. ([Agence Octo methodology])
The practical read for OEM scouts and brand operators
Watch the stack, not any single signal.
FDA 510(k) visibility is one signal. Product-form overlap is another. Country fit is another. Export pattern, partnership posture, and manufacturing structure are separate questions. ([Agence Octo methodology])
The June concentration read suggests one simple operating reality: Respiratory & Sleep does not look like an empty field in this filtered snapshot. Buyers scouting here should expect more visible incumbency, more repeat-filing players, and less value in surface-level "FDA-cleared" claims by themselves. ([FDA CDRH public database] + [Agence Octo methodology])
If you are screening this category, start by separating three groups:
- repeat clearance holders,
- one-off clearance holders,
- companies whose public record sits in adjacent diagnostics rather than device hardware.
Then turn that into a short action path:
- pull the repeat filers first;
- check whether the visible clearances are core devices, accessories, or variants;
- separate respiratory hardware players from diagnostics-heavy mixed-lens companies;
- verify whether the company entity in the FDA record matches the operating entity you would contact;
- check whether the named company is part of the seven disclosed here or one of the three undisclosed top-10 entries before using the 65-clearance total as a comparison point;
- only then move the shortlist into outreach or factory-fit review.
That screen will not choose the partner for you. It will help you diagnose what kind of counterparty each clearance holder may be before you treat them as comparable. Periscope is most useful here as a workflow aid: use it to monitor which names keep reappearing by lens and product pattern before you spend time on outreach. ([Agence Octo methodology])
How Agence Octo helps
Periscope helps buyers track who is showing up repeatedly in public product and trade signals by category, not just who appears once in a database.
Agence Octo Periscope surfaces these market-density patterns automatically — see how it works.